| Primary | Reduction Ratio of Lambda Immunoglobulin FLC at Week 24 | | Full Analysis Set. Number of subjects (n) with evaluable data is shown. | Posted | | Mean | Standard Deviation | percentage ratio | | Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Theranova 400 | Three (3) dialysis sessions per week in an in-center setting over 24-week period. Theranova 400 dialyzer: Patients should continue with their pre-study hemodialysis prescriptions (in terms of treatment time, blood flow rate and dialysate flow rate) and prescriptions should be kept stable throughout the study. | | OG001 | Elisio-17H | Three (3) dialysis sessions per week in an in-center setting over 24-week period. Elisio-17H dialyzer: Patients should continue with their pre-study hemodialysis prescriptions (in terms of treatment time, blood flow rate and dialysate flow rate) and prescriptions should be kept stable throughout the study. |
| | | Title | Denominators | Categories |
|---|
| | | Title | Measurements |
|---|
| - OG00032.156± 12.602
- OG00117.514± 12.7235
|
|
| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
|---|
| If the lower bound of the two-sided 95% confidence interval around the difference between Theranova 400 and Elisio-17H is > 0 then superiority will be demonstrated. | | | | | Mean Difference (Final Values) | 14.828 | | | 2-Sided | 95 | 10.501 | 19.156 | | | | | Superiority | | |
|
| Primary | Pre-dialysis Serum Level of Albumin at Week 24 | | FAS. Number of subjects (n) with evaluable data is shown. | Posted | | Mean | Standard Deviation | g/dL | | Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Theranova 400 | Three (3) dialysis sessions per week in an in-center setting over 24-week period. Theranova 400 dialyzer: Patients should continue with their pre-study hemodialysis prescriptions (in terms of treatment time, blood flow rate and dialysate flow rate) and prescriptions should be kept stable throughout the study. | | OG001 | Elisio-17H | Three (3) dialysis sessions per week in an in-center setting over 24-week period. Elisio-17H dialyzer: Patients should continue with their pre-study hemodialysis prescriptions (in terms of treatment time, blood flow rate and dialysate flow rate) and prescriptions should be kept stable throughout the study. |
| |
| Secondary | Reduction Ratio of Lambda Immunoglobulin FLC at Week 4 and Week 24 | | FAS. Number of subjects (n) with evaluable data is shown. | Posted | | Mean | Standard Deviation | percentage ratio | | Week 4 and Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Theranova 400 | Three (3) dialysis sessions per week in an in-center setting over 24-week period. Theranova 400 dialyzer: Patients should continue with their pre-study hemodialysis prescriptions (in terms of treatment time, blood flow rate and dialysate flow rate) and prescriptions should be kept stable throughout the study. | | OG001 | Elisio-17H | Three (3) dialysis sessions per week in an in-center setting over 24-week period. Elisio-17H dialyzer: Patients should continue with their pre-study hemodialysis prescriptions (in terms of treatment time, blood flow rate and dialysate flow rate) and prescriptions should be kept stable throughout the study. |
| |
| Secondary | Reduction Ratio of Complement Factor D | | FAS. Number of subjects (n) with evaluable data is shown. | Posted | | Mean | Standard Deviation | percentage ratio | | Week 4 and 24 | | | | ID | Title | Description |
|---|
| OG000 | Theranova 400 | Three (3) dialysis sessions per week in an in-center setting over 24-week period. Theranova 400 dialyzer: Patients should continue with their pre-study hemodialysis prescriptions (in terms of treatment time, blood flow rate and dialysate flow rate) and prescriptions should be kept stable throughout the study. | | OG001 | Elisio-17H | Three (3) dialysis sessions per week in an in-center setting over 24-week period. Elisio-17H dialyzer: Patients should continue with their pre-study hemodialysis prescriptions (in terms of treatment time, blood flow rate and dialysate flow rate) and prescriptions should be kept stable throughout the study. |
| |
| Secondary | Reduction Ratio of κ FLC | κ FLC = Kappa Free light chains | FAS. Number of subjects (n) with evaluable data is shown. | Posted | | Mean | Standard Deviation | percentage ratio | | Week 4 and 24 | | | | ID | Title | Description |
|---|
| OG000 | Theranova 400 | Three (3) dialysis sessions per week in an in-center setting over 24-week period. Theranova 400 dialyzer: Patients should continue with their pre-study hemodialysis prescriptions (in terms of treatment time, blood flow rate and dialysate flow rate) and prescriptions should be kept stable throughout the study. | | OG001 | Elisio-17H | Three (3) dialysis sessions per week in an in-center setting over 24-week period. Elisio-17H dialyzer: Patients should continue with their pre-study hemodialysis prescriptions (in terms of treatment time, blood flow rate and dialysate flow rate) and prescriptions should be kept stable throughout the study. |
| |
| Secondary | Reduction Ratio of Interleukin 6 | | FAS. Number of subjects (n) with evaluable data is shown. | Posted | | Mean | Standard Deviation | percentage ratio | | Week 4 and 24 | | | | ID | Title | Description |
|---|
| OG000 | Theranova 400 | Three (3) dialysis sessions per week in an in-center setting over 24-week period. Theranova 400 dialyzer: Patients should continue with their pre-study hemodialysis prescriptions (in terms of treatment time, blood flow rate and dialysate flow rate) and prescriptions should be kept stable throughout the study. | | OG001 | Elisio-17H | Three (3) dialysis sessions per week in an in-center setting over 24-week period. Elisio-17H dialyzer: Patients should continue with their pre-study hemodialysis prescriptions (in terms of treatment time, blood flow rate and dialysate flow rate) and prescriptions should be kept stable throughout the study. |
| |
| Secondary | Reduction Ratio of Tumor Necrosis Factor Alpha | TNFα=tumor necrosis factor alpha | FAS. Number of subjects (n) with evaluable data is shown. | Posted | | Mean | Standard Deviation | percentage ratio | | Week 4 and 24 | | | | ID | Title | Description |
|---|
| OG000 | Theranova 400 | Three (3) dialysis sessions per week in an in-center setting over 24-week period. Theranova 400 dialyzer: Patients should continue with their pre-study hemodialysis prescriptions (in terms of treatment time, blood flow rate and dialysate flow rate) and prescriptions should be kept stable throughout the study. | | OG001 | Elisio-17H | Three (3) dialysis sessions per week in an in-center setting over 24-week period. Elisio-17H dialyzer: Patients should continue with their pre-study hemodialysis prescriptions (in terms of treatment time, blood flow rate and dialysate flow rate) and prescriptions should be kept stable throughout the study. |
| |
| Secondary | Reduction Ratio of β2-microglobulin | | FAS. Number of subjects (n) with evaluable data is shown. | Posted | | Mean | Standard Deviation | percentage ratio | | Week 4 and 24 | | | | ID | Title | Description |
|---|
| OG000 | Theranova 400 | Three (3) dialysis sessions per week in an in-center setting over 24-week period. Theranova 400 dialyzer: Patients should continue with their pre-study hemodialysis prescriptions (in terms of treatment time, blood flow rate and dialysate flow rate) and prescriptions should be kept stable throughout the study. | | OG001 | Elisio-17H | Three (3) dialysis sessions per week in an in-center setting over 24-week period. Elisio-17H dialyzer: Patients should continue with their pre-study hemodialysis prescriptions (in terms of treatment time, blood flow rate and dialysate flow rate) and prescriptions should be kept stable throughout the study. |
| |
| Secondary | Change From Baseline in Pre-dialysis β2-microglobulin at Week 24 | | FAS. Number of subjects (n) with evaluable data is shown. | Posted | | Mean | Standard Deviation | mg/L | | Baseline, Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Theranova 400 | Three (3) dialysis sessions per week in an in-center setting over 24-week period. Theranova 400 dialyzer: Patients should continue with their pre-study hemodialysis prescriptions (in terms of treatment time, blood flow rate and dialysate flow rate) and prescriptions should be kept stable throughout the study. | | OG001 | Elisio-17H | Three (3) dialysis sessions per week in an in-center setting over 24-week period. Elisio-17H dialyzer: Patients should continue with their pre-study hemodialysis prescriptions (in terms of treatment time, blood flow rate and dialysate flow rate) and prescriptions should be kept stable throughout the study. |
| |
| Secondary | Kt/Vurea | Kt/Vurea = Dimensionless number used to quantify hemodialysis and peritoneal dialysis adequacy. | FAS. Number of subjects (n) with evaluable data is shown. | Posted | | Mean | Standard Deviation | Kt/Vurea | | Week 4, 8, 12, 16, 20, 24 | | | | ID | Title | Description |
|---|
| OG000 | Theranova 400 | Three (3) dialysis sessions per week in an in-center setting over 24-week period. Theranova 400 dialyzer: Patients should continue with their pre-study hemodialysis prescriptions (in terms of treatment time, blood flow rate and dialysate flow rate) and prescriptions should be kept stable throughout the study. | | OG001 | Elisio-17H | Three (3) dialysis sessions per week in an in-center setting over 24-week period. Elisio-17H dialyzer: Patients should continue with their pre-study hemodialysis prescriptions (in terms of treatment time, blood flow rate and dialysate flow rate) and prescriptions should be kept stable throughout the study. |
| |
| Secondary | Change From Baseline in Pre-dialysis Serum Albumin by Visit | | FAS. Number of subjects (n) with evaluable data is shown. | Posted | | Mean | Standard Deviation | g/dL | | Baseline, Week 4, 8, 12, 16, 20, 24 | | | | ID | Title | Description |
|---|
| OG000 | Theranova 400 | Three (3) dialysis sessions per week in an in-center setting over 24-week period. Theranova 400 dialyzer: Patients should continue with their pre-study hemodialysis prescriptions (in terms of treatment time, blood flow rate and dialysate flow rate) and prescriptions should be kept stable throughout the study. | | OG001 | Elisio-17H | Three (3) dialysis sessions per week in an in-center setting over 24-week period. Elisio-17H dialyzer: Patients should continue with their pre-study hemodialysis prescriptions (in terms of treatment time, blood flow rate and dialysate flow rate) and prescriptions should be kept stable throughout the study. |
| |
| Secondary | Change From Baseline in Pre-dialysis Factor VII by Visit | | FAS. Number of subjects (n) with evaluable data is shown. | Posted | | Mean | Standard Deviation | percentage activity | | Baseline, Week 12, Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Theranova 400 | Three (3) dialysis sessions per week in an in-center setting over 24-week period. Theranova 400 dialyzer: Patients should continue with their pre-study hemodialysis prescriptions (in terms of treatment time, blood flow rate and dialysate flow rate) and prescriptions should be kept stable throughout the study. | | OG001 | Elisio-17H | Three (3) dialysis sessions per week in an in-center setting over 24-week period. Elisio-17H dialyzer: Patients should continue with their pre-study hemodialysis prescriptions (in terms of treatment time, blood flow rate and dialysate flow rate) and prescriptions should be kept stable throughout the study. |
| |
| Secondary | Change From Baseline in Pre-dialysis Protein C by Visit | | FAS. Number of subjects (n) with evaluable data is shown. | Posted | | Mean | Standard Deviation | percentage activity | | Baseline, Week 12, Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Theranova 400 | Three (3) dialysis sessions per week in an in-center setting over 24-week period. Theranova 400 dialyzer: Patients should continue with their pre-study hemodialysis prescriptions (in terms of treatment time, blood flow rate and dialysate flow rate) and prescriptions should be kept stable throughout the study. | | OG001 | Elisio-17H | Three (3) dialysis sessions per week in an in-center setting over 24-week period. Elisio-17H dialyzer: Patients should continue with their pre-study hemodialysis prescriptions (in terms of treatment time, blood flow rate and dialysate flow rate) and prescriptions should be kept stable throughout the study. |
| |
| Secondary | Change From Baseline in Pre-dialysis Vitamin A by Visit | | FAS. Number of subjects (n) with evaluable data is shown. | Posted | | Mean | Standard Deviation | μmol/L | | Baseline, Week 4, Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Theranova 400 | Three (3) dialysis sessions per week in an in-center setting over 24-week period. Theranova 400 dialyzer: Patients should continue with their pre-study hemodialysis prescriptions (in terms of treatment time, blood flow rate and dialysate flow rate) and prescriptions should be kept stable throughout the study. | | OG001 | Elisio-17H | Three (3) dialysis sessions per week in an in-center setting over 24-week period. Elisio-17H dialyzer: Patients should continue with their pre-study hemodialysis prescriptions (in terms of treatment time, blood flow rate and dialysate flow rate) and prescriptions should be kept stable throughout the study. |
| |
| Secondary | nPNA (nPCR) | nPNA=normalized Protein equivalent of Nitrogen Appearance, and nPCR=normalized Protein Catabolic Rate. | FAS. Number of subjects (n) with evaluable data is shown. | Posted | | Mean | Standard Deviation | g/kg/d | | Week 4, 8, 12, 16, 20, 24 | | | | ID | Title | Description |
|---|
| OG000 | Theranova 400 | Three (3) dialysis sessions per week in an in-center setting over 24-week period. Theranova 400 dialyzer: Patients should continue with their pre-study hemodialysis prescriptions (in terms of treatment time, blood flow rate and dialysate flow rate) and prescriptions should be kept stable throughout the study. | | OG001 | Elisio-17H | Three (3) dialysis sessions per week in an in-center setting over 24-week period. Elisio-17H dialyzer: Patients should continue with their pre-study hemodialysis prescriptions (in terms of treatment time, blood flow rate and dialysate flow rate) and prescriptions should be kept stable throughout the study. |
| |
| Secondary | Change From Baseline in Pre-dialysis Factor II by Visit | | FAS. Number of subjects (n) with evaluable data is shown. | Posted | | Mean | Standard Deviation | percent activity | | Baseline, Week 12, Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Theranova 400 | Three (3) dialysis sessions per week in an in-center setting over 24-week period. Theranova 400 dialyzer: Patients should continue with their pre-study hemodialysis prescriptions (in terms of treatment time, blood flow rate and dialysate flow rate) and prescriptions should be kept stable throughout the study. | | OG001 | Elisio-17H | Three (3) dialysis sessions per week in an in-center setting over 24-week period. Elisio-17H dialyzer: Patients should continue with their pre-study hemodialysis prescriptions (in terms of treatment time, blood flow rate and dialysate flow rate) and prescriptions should be kept stable throughout the study. |
| |
| Secondary | Change From Baseline in Sodium (mmol/L) at End of Study (up to Week 24) | | FAS. Number of subjects (n) with evaluable data is shown. | Posted | | Mean | Standard Deviation | mmol/L | | Baseline and Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Theranova 400 | Three (3) dialysis sessions per week in an in-center setting over 24-week period. Theranova 400 dialyzer: Patients should continue with their pre-study hemodialysis prescriptions (in terms of treatment time, blood flow rate and dialysate flow rate) and prescriptions should be kept stable throughout the study. | | OG001 | Elisio-17H | Three (3) dialysis sessions per week in an in-center setting over 24-week period. Elisio-17H dialyzer: Patients should continue with their pre-study hemodialysis prescriptions (in terms of treatment time, blood flow rate and dialysate flow rate) and prescriptions should be kept stable throughout the study. |
| |
| Secondary | Change From Baseline in Potassium (mmol/L) at End of Study (up to Week 24) | | FAS. Number of subjects (n) with evaluable data is shown. | Posted | | Mean | Standard Deviation | mmol/L | | Baseline and Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Theranova 400 | Three (3) dialysis sessions per week in an in-center setting over 24-week period. Theranova 400 dialyzer: Patients should continue with their pre-study hemodialysis prescriptions (in terms of treatment time, blood flow rate and dialysate flow rate) and prescriptions should be kept stable throughout the study. | | OG001 | Elisio-17H | Three (3) dialysis sessions per week in an in-center setting over 24-week period. Elisio-17H dialyzer: Patients should continue with their pre-study hemodialysis prescriptions (in terms of treatment time, blood flow rate and dialysate flow rate) and prescriptions should be kept stable throughout the study. |
| |
| Secondary | Change From Baseline in Calcium (mmol/L) at End of Study (up to Week 24) | | FAS. Number of subjects (n) with evaluable data is shown. | Posted | | Mean | Standard Deviation | mmol/L | | Baseline, Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Theranova 400 | Three (3) dialysis sessions per week in an in-center setting over 24-week period. Theranova 400 dialyzer: Patients should continue with their pre-study hemodialysis prescriptions (in terms of treatment time, blood flow rate and dialysate flow rate) and prescriptions should be kept stable throughout the study. | | OG001 | Elisio-17H | Three (3) dialysis sessions per week in an in-center setting over 24-week period. Elisio-17H dialyzer: Patients should continue with their pre-study hemodialysis prescriptions (in terms of treatment time, blood flow rate and dialysate flow rate) and prescriptions should be kept stable throughout the study. |
| |
| Secondary | Change From Baseline in Phosphate (mmol/L) at End of Study (up to Week 24) | | FAS. Number of subjects (n) with evaluable data is shown. | Posted | | Mean | Standard Deviation | mmol/L | | Baseline, Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Theranova 400 | Three (3) dialysis sessions per week in an in-center setting over 24-week period. Theranova 400 dialyzer: Patients should continue with their pre-study hemodialysis prescriptions (in terms of treatment time, blood flow rate and dialysate flow rate) and prescriptions should be kept stable throughout the study. | | OG001 | Elisio-17H | Three (3) dialysis sessions per week in an in-center setting over 24-week period. Elisio-17H dialyzer: Patients should continue with their pre-study hemodialysis prescriptions (in terms of treatment time, blood flow rate and dialysate flow rate) and prescriptions should be kept stable throughout the study. |
| |
| Secondary | Change From Baseline in Chloride (mmol/L) at End of Study (up to Week 24) | | FAS. Number of subjects (n) with evaluable data is shown. | Posted | | Mean | Standard Deviation | mmol/L | | Baseline, Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Theranova 400 | Three (3) dialysis sessions per week in an in-center setting over 24-week period. Theranova 400 dialyzer: Patients should continue with their pre-study hemodialysis prescriptions (in terms of treatment time, blood flow rate and dialysate flow rate) and prescriptions should be kept stable throughout the study. | | OG001 | Elisio-17H | Three (3) dialysis sessions per week in an in-center setting over 24-week period. Elisio-17H dialyzer: Patients should continue with their pre-study hemodialysis prescriptions (in terms of treatment time, blood flow rate and dialysate flow rate) and prescriptions should be kept stable throughout the study. |
| |
| Secondary | Change From Baseline in Bicarbonate (mmol/L) at End of Study (up to Week 24) | | FAS. Number of subjects (n) with evaluable data is shown. | Posted | | Mean | Standard Deviation | mmol/L | | Baseline, Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Theranova 400 | Three (3) dialysis sessions per week in an in-center setting over 24-week period. Theranova 400 dialyzer: Patients should continue with their pre-study hemodialysis prescriptions (in terms of treatment time, blood flow rate and dialysate flow rate) and prescriptions should be kept stable throughout the study. | | OG001 | Elisio-17H | Three (3) dialysis sessions per week in an in-center setting over 24-week period. Elisio-17H dialyzer: Patients should continue with their pre-study hemodialysis prescriptions (in terms of treatment time, blood flow rate and dialysate flow rate) and prescriptions should be kept stable throughout the study. |
| |
| Secondary | Change From Baseline in Glucose (mmol/L) at End of Study (up to Week 24) | | FAS. Number of subjects (n) with evaluable data is shown. | Posted | | Mean | Standard Deviation | mmol/L | | Baseline, Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Theranova 400 | Three (3) dialysis sessions per week in an in-center setting over 24-week period. Theranova 400 dialyzer: Patients should continue with their pre-study hemodialysis prescriptions (in terms of treatment time, blood flow rate and dialysate flow rate) and prescriptions should be kept stable throughout the study. | | OG001 | Elisio-17H | Three (3) dialysis sessions per week in an in-center setting over 24-week period. Elisio-17H dialyzer: Patients should continue with their pre-study hemodialysis prescriptions (in terms of treatment time, blood flow rate and dialysate flow rate) and prescriptions should be kept stable throughout the study. |
| |
| Secondary | Change From Baseline in Prothrombin Time (Sec) at End of Study (up to Week 24) | | FAS. Number of subjects (n) with evaluable data is shown. | Posted | | Mean | Standard Deviation | Sec | | Baseline, Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Theranova 400 | Three (3) dialysis sessions per week in an in-center setting over 24-week period. Theranova 400 dialyzer: Patients should continue with their pre-study hemodialysis prescriptions (in terms of treatment time, blood flow rate and dialysate flow rate) and prescriptions should be kept stable throughout the study. | | OG001 | Elisio-17H | Three (3) dialysis sessions per week in an in-center setting over 24-week period. Elisio-17H dialyzer: Patients should continue with their pre-study hemodialysis prescriptions (in terms of treatment time, blood flow rate and dialysate flow rate) and prescriptions should be kept stable throughout the study. |
| |
| Secondary | Change From Baseline in Prothrombin Intl. Normalized Ratio at End of Study (up to Week 24) | | FAS. Number of subjects (n) with evaluable data is shown. | Posted | | Mean | Standard Deviation | ratio | | Baseline, Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Theranova 400 | Three (3) dialysis sessions per week in an in-center setting over 24-week period. Theranova 400 dialyzer: Patients should continue with their pre-study hemodialysis prescriptions (in terms of treatment time, blood flow rate and dialysate flow rate) and prescriptions should be kept stable throughout the study. | | OG001 | Elisio-17H | Three (3) dialysis sessions per week in an in-center setting over 24-week period. Elisio-17H dialyzer: Patients should continue with their pre-study hemodialysis prescriptions (in terms of treatment time, blood flow rate and dialysate flow rate) and prescriptions should be kept stable throughout the study. |
| |
| Secondary | Change From Baseline in Activated Partial Thromboplastin Time (Sec) at End of Study (up to Week 24) | | FAS. Number of subjects (n) with evaluable data is shown. | Posted | | Mean | Standard Deviation | Sec | | Baseline, Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Theranova 400 | Three (3) dialysis sessions per week in an in-center setting over 24-week period. Theranova 400 dialyzer: Patients should continue with their pre-study hemodialysis prescriptions (in terms of treatment time, blood flow rate and dialysate flow rate) and prescriptions should be kept stable throughout the study. | | OG001 | Elisio-17H | Three (3) dialysis sessions per week in an in-center setting over 24-week period. Elisio-17H dialyzer: Patients should continue with their pre-study hemodialysis prescriptions (in terms of treatment time, blood flow rate and dialysate flow rate) and prescriptions should be kept stable throughout the study. |
| |
| Secondary | Change From Baseline in Hematocrit (L/L) at End of Study (up to Week 24) | | FAS. Number of subjects (n) with evaluable data is shown. | Posted | | Mean | Standard Deviation | L/L | | Baseline, Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Theranova 400 | Three (3) dialysis sessions per week in an in-center setting over 24-week period. Theranova 400 dialyzer: Patients should continue with their pre-study hemodialysis prescriptions (in terms of treatment time, blood flow rate and dialysate flow rate) and prescriptions should be kept stable throughout the study. | | OG001 | Elisio-17H | Three (3) dialysis sessions per week in an in-center setting over 24-week period. Elisio-17H dialyzer: Patients should continue with their pre-study hemodialysis prescriptions (in terms of treatment time, blood flow rate and dialysate flow rate) and prescriptions should be kept stable throughout the study. |
| |
| Secondary | Change From Baseline in Hemoglobin (g/L) at End of Study (up to Week 24) | | FAS. Number of subjects (n) with evaluable data is shown. | Posted | | Mean | Standard Deviation | g/L | | Baseline, Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Theranova 400 | Three (3) dialysis sessions per week in an in-center setting over 24-week period. Theranova 400 dialyzer: Patients should continue with their pre-study hemodialysis prescriptions (in terms of treatment time, blood flow rate and dialysate flow rate) and prescriptions should be kept stable throughout the study. | | OG001 | Elisio-17H | Three (3) dialysis sessions per week in an in-center setting over 24-week period. Elisio-17H dialyzer: Patients should continue with their pre-study hemodialysis prescriptions (in terms of treatment time, blood flow rate and dialysate flow rate) and prescriptions should be kept stable throughout the study. |
| |
| Secondary | Change From Baseline in Erythrocyte Mean Corpuscular Hemoglobin (pg) at End of Study (up to Week 24) | | FAS. Number of subjects (n) with evaluable data is shown. | Posted | | Mean | Standard Deviation | pg | | Baseline, Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Theranova 400 | Three (3) dialysis sessions per week in an in-center setting over 24-week period. Theranova 400 dialyzer: Patients should continue with their pre-study hemodialysis prescriptions (in terms of treatment time, blood flow rate and dialysate flow rate) and prescriptions should be kept stable throughout the study. | | OG001 | Elisio-17H | Three (3) dialysis sessions per week in an in-center setting over 24-week period. Elisio-17H dialyzer: Patients should continue with their pre-study hemodialysis prescriptions (in terms of treatment time, blood flow rate and dialysate flow rate) and prescriptions should be kept stable throughout the study. |
| |
| Secondary | Change From Baseline in Erythrocyte Mean Corpuscular HGB Concentration (g/L) at End of Study (up to Week 24) | | FAS. Number of subjects (n) with evaluable data is shown. | Posted | | Mean | Standard Deviation | g/L | | Baseline, Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Theranova 400 | Three (3) dialysis sessions per week in an in-center setting over 24-week period. Theranova 400 dialyzer: Patients should continue with their pre-study hemodialysis prescriptions (in terms of treatment time, blood flow rate and dialysate flow rate) and prescriptions should be kept stable throughout the study. | | OG001 | Elisio-17H | Three (3) dialysis sessions per week in an in-center setting over 24-week period. Elisio-17H dialyzer: Patients should continue with their pre-study hemodialysis prescriptions (in terms of treatment time, blood flow rate and dialysate flow rate) and prescriptions should be kept stable throughout the study. |
| |
| Secondary | Change From Baseline in Erythrocyte Mean Corpuscular Volume (fL) at End of Study (up to Week 24) | | FAS. Number of subjects (n) with evaluable data is shown. | Posted | | Mean | Standard Deviation | fL | | Baseline, Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Theranova 400 | Three (3) dialysis sessions per week in an in-center setting over 24-week period. Theranova 400 dialyzer: Patients should continue with their pre-study hemodialysis prescriptions (in terms of treatment time, blood flow rate and dialysate flow rate) and prescriptions should be kept stable throughout the study. | | OG001 | Elisio-17H | Three (3) dialysis sessions per week in an in-center setting over 24-week period. Elisio-17H dialyzer: Patients should continue with their pre-study hemodialysis prescriptions (in terms of treatment time, blood flow rate and dialysate flow rate) and prescriptions should be kept stable throughout the study. |
| |
| Secondary | Change From Baseline in Platelets at End of Study (up to Week 24) | | FAS. Number of subjects (n) with evaluable data is shown. | Posted | | Mean | Standard Deviation | 10^9 cells/L | | Baseline, Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Theranova 400 | Three (3) dialysis sessions per week in an in-center setting over 24-week period. Theranova 400 dialyzer: Patients should continue with their pre-study hemodialysis prescriptions (in terms of treatment time, blood flow rate and dialysate flow rate) and prescriptions should be kept stable throughout the study. | | OG001 | Elisio-17H | Three (3) dialysis sessions per week in an in-center setting over 24-week period. Elisio-17H dialyzer: Patients should continue with their pre-study hemodialysis prescriptions (in terms of treatment time, blood flow rate and dialysate flow rate) and prescriptions should be kept stable throughout the study. |
| |
| Secondary | Change From Baseline in Erythrocytes at End of Study (up to Week 24) | | FAS. Number of subjects (n) with evaluable data is shown. | Posted | | Mean | Standard Deviation | 10^12 cells/L | | Baseline, Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Theranova 400 | Three (3) dialysis sessions per week in an in-center setting over 24-week period. Theranova 400 dialyzer: Patients should continue with their pre-study hemodialysis prescriptions (in terms of treatment time, blood flow rate and dialysate flow rate) and prescriptions should be kept stable throughout the study. | | OG001 | Elisio-17H | Three (3) dialysis sessions per week in an in-center setting over 24-week period. Elisio-17H dialyzer: Patients should continue with their pre-study hemodialysis prescriptions (in terms of treatment time, blood flow rate and dialysate flow rate) and prescriptions should be kept stable throughout the study. |
| |
| Secondary | Change From Baseline in Leukocytes at End of Study (up to Week 24) | | FAS. Number of subjects (n) with evaluable data is shown. | Posted | | Mean | Standard Deviation | 10^9 cells/L | | Baseline, Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Theranova 400 | Three (3) dialysis sessions per week in an in-center setting over 24-week period. Theranova 400 dialyzer: Patients should continue with their pre-study hemodialysis prescriptions (in terms of treatment time, blood flow rate and dialysate flow rate) and prescriptions should be kept stable throughout the study. | | OG001 | Elisio-17H | Three (3) dialysis sessions per week in an in-center setting over 24-week period. Elisio-17H dialyzer: Patients should continue with their pre-study hemodialysis prescriptions (in terms of treatment time, blood flow rate and dialysate flow rate) and prescriptions should be kept stable throughout the study. |
| |
| Secondary | Change From Baseline in Basophils (%) at End of Study (up to Week 24) | | FAS. Number of subjects (n) with evaluable data is shown. | Posted | | Mean | Standard Deviation | % of total white blood count (WBC) | | Baseline, Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Theranova 400 | Three (3) dialysis sessions per week in an in-center setting over 24-week period. Theranova 400 dialyzer: Patients should continue with their pre-study hemodialysis prescriptions (in terms of treatment time, blood flow rate and dialysate flow rate) and prescriptions should be kept stable throughout the study. | | OG001 | Elisio-17H | Three (3) dialysis sessions per week in an in-center setting over 24-week period. Elisio-17H dialyzer: Patients should continue with their pre-study hemodialysis prescriptions (in terms of treatment time, blood flow rate and dialysate flow rate) and prescriptions should be kept stable throughout the study. |
| |
| Secondary | Change From Baseline in Eosinophils (%) at End of Study (up to Week 24) | | FAS. Number of subjects (n) with evaluable data is shown. | Posted | | Mean | Standard Deviation | % of total WBC | | Baseline, Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Theranova 400 | Three (3) dialysis sessions per week in an in-center setting over 24-week period. Theranova 400 dialyzer: Patients should continue with their pre-study hemodialysis prescriptions (in terms of treatment time, blood flow rate and dialysate flow rate) and prescriptions should be kept stable throughout the study. | | OG001 | Elisio-17H | Three (3) dialysis sessions per week in an in-center setting over 24-week period. Elisio-17H dialyzer: Patients should continue with their pre-study hemodialysis prescriptions (in terms of treatment time, blood flow rate and dialysate flow rate) and prescriptions should be kept stable throughout the study. |
| |
| Secondary | Change From Baseline in Lymphocytes (%) at End of Study (up to Week 24) | | FAS. Number of subjects (n) with evaluable data is shown. | Posted | | Mean | Standard Deviation | % of total WBC | | Baseline, Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Theranova 400 | Three (3) dialysis sessions per week in an in-center setting over 24-week period. Theranova 400 dialyzer: Patients should continue with their pre-study hemodialysis prescriptions (in terms of treatment time, blood flow rate and dialysate flow rate) and prescriptions should be kept stable throughout the study. | | OG001 | Elisio-17H | Three (3) dialysis sessions per week in an in-center setting over 24-week period. Elisio-17H dialyzer: Patients should continue with their pre-study hemodialysis prescriptions (in terms of treatment time, blood flow rate and dialysate flow rate) and prescriptions should be kept stable throughout the study. |
| |
| Secondary | Change From Baseline in Monocytes (%) at End of Study (up to Week 24) | | FAS. Number of subjects (n) with evaluable data is shown. | Posted | | Mean | Standard Deviation | % of total WBC | | Baseline, Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Theranova 400 | Three (3) dialysis sessions per week in an in-center setting over 24-week period. Theranova 400 dialyzer: Patients should continue with their pre-study hemodialysis prescriptions (in terms of treatment time, blood flow rate and dialysate flow rate) and prescriptions should be kept stable throughout the study. | | OG001 | Elisio-17H | Three (3) dialysis sessions per week in an in-center setting over 24-week period. Elisio-17H dialyzer: Patients should continue with their pre-study hemodialysis prescriptions (in terms of treatment time, blood flow rate and dialysate flow rate) and prescriptions should be kept stable throughout the study. |
| |
| Secondary | Change From Baseline in Neutrophils (%) at End of Study (up to Week 24) | | FAS. Number of subjects (n) with evaluable data is shown. | Posted | | Mean | Standard Deviation | % of total WBC | | Baseline, Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Theranova 400 | Three (3) dialysis sessions per week in an in-center setting over 24-week period. Theranova 400 dialyzer: Patients should continue with their pre-study hemodialysis prescriptions (in terms of treatment time, blood flow rate and dialysate flow rate) and prescriptions should be kept stable throughout the study. | | OG001 | Elisio-17H | Three (3) dialysis sessions per week in an in-center setting over 24-week period. Elisio-17H dialyzer: Patients should continue with their pre-study hemodialysis prescriptions (in terms of treatment time, blood flow rate and dialysate flow rate) and prescriptions should be kept stable throughout the study. |
| |
| Secondary | Change From Baseline in Pre-Dialysis Blood Urea Nitrogen (mmol Urea/L) at End of Study (up to Week 24) | | FAS. Number of subjects (n) with evaluable data is shown. | Posted | | Mean | Standard Deviation | mmol urea/L | | Baseline, Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Theranova 400 | Three (3) dialysis sessions per week in an in-center setting over 24-week period. Theranova 400 dialyzer: Patients should continue with their pre-study hemodialysis prescriptions (in terms of treatment time, blood flow rate and dialysate flow rate) and prescriptions should be kept stable throughout the study. | | OG001 | Elisio-17H | Three (3) dialysis sessions per week in an in-center setting over 24-week period. Elisio-17H dialyzer: Patients should continue with their pre-study hemodialysis prescriptions (in terms of treatment time, blood flow rate and dialysate flow rate) and prescriptions should be kept stable throughout the study. |
| |
| Secondary | Change From Baseline in Post-Dialysis Blood Urea Nitrogen (mmol Urea/L) at End of Study (up to Week 24) | | FAS. Number of subjects (n) with evaluable data is shown. | Posted | | Mean | Standard Deviation | mmol urea/L | | Baseline, Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Theranova 400 | Three (3) dialysis sessions per week in an in-center setting over 24-week period. Theranova 400 dialyzer: Patients should continue with their pre-study hemodialysis prescriptions (in terms of treatment time, blood flow rate and dialysate flow rate) and prescriptions should be kept stable throughout the study. | | OG001 | Elisio-17H | Three (3) dialysis sessions per week in an in-center setting over 24-week period. Elisio-17H dialyzer: Patients should continue with their pre-study hemodialysis prescriptions (in terms of treatment time, blood flow rate and dialysate flow rate) and prescriptions should be kept stable throughout the study. |
| |
| Secondary | Change From Baseline in BUN Reduction Ratio at End of Study (up to Week 24) | | FAS. Number of subjects (n) with evaluable data is shown. | Posted | | Mean | Standard Deviation | no unit | | Baseline, Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Theranova 400 | Three (3) dialysis sessions per week in an in-center setting over 24-week period. Theranova 400 dialyzer: Patients should continue with their pre-study hemodialysis prescriptions (in terms of treatment time, blood flow rate and dialysate flow rate) and prescriptions should be kept stable throughout the study. | | OG001 | Elisio-17H | Three (3) dialysis sessions per week in an in-center setting over 24-week period. Elisio-17H dialyzer: Patients should continue with their pre-study hemodialysis prescriptions (in terms of treatment time, blood flow rate and dialysate flow rate) and prescriptions should be kept stable throughout the study. |
| |
| Secondary | Change From Baseline in Creatinine (μmol/L) at End of Study (up to Week 24) | | FAS. Number of subjects (n) with evaluable data is shown. | Posted | | Mean | Standard Deviation | μmol/L | | Baseline, Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Theranova 400 | Three (3) dialysis sessions per week in an in-center setting over 24-week period. Theranova 400 dialyzer: Patients should continue with their pre-study hemodialysis prescriptions (in terms of treatment time, blood flow rate and dialysate flow rate) and prescriptions should be kept stable throughout the study. | | OG001 | Elisio-17H | Three (3) dialysis sessions per week in an in-center setting over 24-week period. Elisio-17H dialyzer: Patients should continue with their pre-study hemodialysis prescriptions (in terms of treatment time, blood flow rate and dialysate flow rate) and prescriptions should be kept stable throughout the study. |
| |
| Secondary | Kt/Vurea by Visit | | FAS. Number of subjects (n) with evaluable data is shown. | Posted | | Mean | Standard Deviation | no unit | | Week 4, Week 8, Week 12, Week 16, Week 20, Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Theranova 400 | Three (3) dialysis sessions per week in an in-center setting over 24-week period. Theranova 400 dialyzer: Patients should continue with their pre-study hemodialysis prescriptions (in terms of treatment time, blood flow rate and dialysate flow rate) and prescriptions should be kept stable throughout the study. | | OG001 | Elisio-17H | Three (3) dialysis sessions per week in an in-center setting over 24-week period. Elisio-17H dialyzer: Patients should continue with their pre-study hemodialysis prescriptions (in terms of treatment time, blood flow rate and dialysate flow rate) and prescriptions should be kept stable throughout the study. |
| |
| Secondary | Change From Baseline in Vitamin A (μmol/L) at End of Study (up to Week 24) | | FAS. Number of subjects (n) with evaluable data is shown. | Posted | | Mean | Standard Deviation | μmol/L | | Baseline, Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Theranova 400 | Three (3) dialysis sessions per week in an in-center setting over 24-week period. Theranova 400 dialyzer: Patients should continue with their pre-study hemodialysis prescriptions (in terms of treatment time, blood flow rate and dialysate flow rate) and prescriptions should be kept stable throughout the study. | | OG001 | Elisio-17H | Three (3) dialysis sessions per week in an in-center setting over 24-week period. Elisio-17H dialyzer: Patients should continue with their pre-study hemodialysis prescriptions (in terms of treatment time, blood flow rate and dialysate flow rate) and prescriptions should be kept stable throughout the study. |
| |
| Secondary | Change From Baseline in Cholesterol (mmol/L) at End of Study (up to Week 24) | | FAS. Number of subjects (n) with evaluable data is shown. | Posted | | Mean | Standard Deviation | mmol/L | | Baseline, Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Theranova 400 | Three (3) dialysis sessions per week in an in-center setting over 24-week period. Theranova 400 dialyzer: Patients should continue with their pre-study hemodialysis prescriptions (in terms of treatment time, blood flow rate and dialysate flow rate) and prescriptions should be kept stable throughout the study. | | OG001 | Elisio-17H | Three (3) dialysis sessions per week in an in-center setting over 24-week period. Elisio-17H dialyzer: Patients should continue with their pre-study hemodialysis prescriptions (in terms of treatment time, blood flow rate and dialysate flow rate) and prescriptions should be kept stable throughout the study. |
| |
| Secondary | Change From Baseline in HDL Cholesterol (mmol/L) at End of Study (up to Week 24) | | FAS. Number of subjects (n) with evaluable data is shown. | Posted | | Mean | Standard Deviation | mmol/L | | Baseline, Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Theranova 400 | Three (3) dialysis sessions per week in an in-center setting over 24-week period. Theranova 400 dialyzer: Patients should continue with their pre-study hemodialysis prescriptions (in terms of treatment time, blood flow rate and dialysate flow rate) and prescriptions should be kept stable throughout the study. | | OG001 | Elisio-17H | Three (3) dialysis sessions per week in an in-center setting over 24-week period. Elisio-17H dialyzer: Patients should continue with their pre-study hemodialysis prescriptions (in terms of treatment time, blood flow rate and dialysate flow rate) and prescriptions should be kept stable throughout the study. |
| |
| Secondary | Change From Baseline in LDL Cholesterol (mmol/L) at End of Study (up to Week 24) | | FAS. Number of subjects (n) with evaluable data is shown. | Posted | | Mean | Standard Deviation | mmol/L | | Baseline, Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Theranova 400 | Three (3) dialysis sessions per week in an in-center setting over 24-week period. Theranova 400 dialyzer: Patients should continue with their pre-study hemodialysis prescriptions (in terms of treatment time, blood flow rate and dialysate flow rate) and prescriptions should be kept stable throughout the study. | | OG001 | Elisio-17H | Three (3) dialysis sessions per week in an in-center setting over 24-week period. Elisio-17H dialyzer: Patients should continue with their pre-study hemodialysis prescriptions (in terms of treatment time, blood flow rate and dialysate flow rate) and prescriptions should be kept stable throughout the study. |
| |
| Secondary | Change From Baseline in Triglycerides (mmol/L) at End of Study (up to Week 24) | | FAS. Number of subjects (n) with evaluable data is shown. | Posted | | Mean | Standard Deviation | mmol/L | | Baseline, Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Theranova 400 | Three (3) dialysis sessions per week in an in-center setting over 24-week period. Theranova 400 dialyzer: Patients should continue with their pre-study hemodialysis prescriptions (in terms of treatment time, blood flow rate and dialysate flow rate) and prescriptions should be kept stable throughout the study. | | OG001 | Elisio-17H | Three (3) dialysis sessions per week in an in-center setting over 24-week period. Elisio-17H dialyzer: Patients should continue with their pre-study hemodialysis prescriptions (in terms of treatment time, blood flow rate and dialysate flow rate) and prescriptions should be kept stable throughout the study. |
| |
| Secondary | Change From Baseline in Alkaline Phosphatase (U/L) at End of Study (up to Week 24) | | FAS. Number of subjects (n) with evaluable data is shown. | Posted | | Mean | Standard Deviation | U/L | | Baseline, Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Theranova 400 | Three (3) dialysis sessions per week in an in-center setting over 24-week period. Theranova 400 dialyzer: Patients should continue with their pre-study hemodialysis prescriptions (in terms of treatment time, blood flow rate and dialysate flow rate) and prescriptions should be kept stable throughout the study. | | OG001 | Elisio-17H | Three (3) dialysis sessions per week in an in-center setting over 24-week period. Elisio-17H dialyzer: Patients should continue with their pre-study hemodialysis prescriptions (in terms of treatment time, blood flow rate and dialysate flow rate) and prescriptions should be kept stable throughout the study. |
| |
| Secondary | Change From Baseline in Alanine Aminotransferase (U/L) at End of Study (up to Week 24) | | FAS. Number of subjects (n) with evaluable data is shown. | Posted | | Mean | Standard Deviation | U/L | | Baseline, Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Theranova 400 | Three (3) dialysis sessions per week in an in-center setting over 24-week period. Theranova 400 dialyzer: Patients should continue with their pre-study hemodialysis prescriptions (in terms of treatment time, blood flow rate and dialysate flow rate) and prescriptions should be kept stable throughout the study. | | OG001 | Elisio-17H | Three (3) dialysis sessions per week in an in-center setting over 24-week period. Elisio-17H dialyzer: Patients should continue with their pre-study hemodialysis prescriptions (in terms of treatment time, blood flow rate and dialysate flow rate) and prescriptions should be kept stable throughout the study. |
| |
| Secondary | Change From Baseline in Aspartate Aminotransferase (U/L) at End of Study (up to Week 24) | | FAS. Number of subjects (n) with evaluable data is shown. | Posted | | Mean | Standard Deviation | U/L | | Baseline, Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Theranova 400 | Three (3) dialysis sessions per week in an in-center setting over 24-week period. Theranova 400 dialyzer: Patients should continue with their pre-study hemodialysis prescriptions (in terms of treatment time, blood flow rate and dialysate flow rate) and prescriptions should be kept stable throughout the study. | | OG001 | Elisio-17H | Three (3) dialysis sessions per week in an in-center setting over 24-week period. Elisio-17H dialyzer: Patients should continue with their pre-study hemodialysis prescriptions (in terms of treatment time, blood flow rate and dialysate flow rate) and prescriptions should be kept stable throughout the study. |
| |
| Secondary | Change From Baseline in Direct Bilirubin (μmol/L) at End of Study (up to Week 24) | | FAS. Number of subjects (n) with evaluable data is shown. | Posted | | Mean | Standard Deviation | μmol/L | | Baseline, Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Theranova 400 | Three (3) dialysis sessions per week in an in-center setting over 24-week period. Theranova 400 dialyzer: Patients should continue with their pre-study hemodialysis prescriptions (in terms of treatment time, blood flow rate and dialysate flow rate) and prescriptions should be kept stable throughout the study. | | OG001 | Elisio-17H | Three (3) dialysis sessions per week in an in-center setting over 24-week period. Elisio-17H dialyzer: Patients should continue with their pre-study hemodialysis prescriptions (in terms of treatment time, blood flow rate and dialysate flow rate) and prescriptions should be kept stable throughout the study. |
| |
| Secondary | Change From Baseline in Bilirubin (μmol/L) at End of Study (up to Week 24) | | FAS. Number of subjects (n) with evaluable data is shown. | Posted | | Mean | Standard Deviation | μmol/L | | Baseline, Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Theranova 400 | Three (3) dialysis sessions per week in an in-center setting over 24-week period. Theranova 400 dialyzer: Patients should continue with their pre-study hemodialysis prescriptions (in terms of treatment time, blood flow rate and dialysate flow rate) and prescriptions should be kept stable throughout the study. | | OG001 | Elisio-17H | Three (3) dialysis sessions per week in an in-center setting over 24-week period. Elisio-17H dialyzer: Patients should continue with their pre-study hemodialysis prescriptions (in terms of treatment time, blood flow rate and dialysate flow rate) and prescriptions should be kept stable throughout the study. |
| |
| Secondary | Change From Baseline in Gamma Glutamyl Transferase (U/L) at End of Study (up to Week 24) | | FAS. Number of subjects (n) with evaluable data is shown. | Posted | | Mean | Standard Deviation | U/L | | Baseline, Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Theranova 400 | Three (3) dialysis sessions per week in an in-center setting over 24-week period. Theranova 400 dialyzer: Patients should continue with their pre-study hemodialysis prescriptions (in terms of treatment time, blood flow rate and dialysate flow rate) and prescriptions should be kept stable throughout the study. | | OG001 | Elisio-17H | Three (3) dialysis sessions per week in an in-center setting over 24-week period. Elisio-17H dialyzer: Patients should continue with their pre-study hemodialysis prescriptions (in terms of treatment time, blood flow rate and dialysate flow rate) and prescriptions should be kept stable throughout the study. |
| |
| Secondary | Change From Baseline in Protein (g/L) at End of Study (up to Week 24) | | FAS. Number of subjects (n) with evaluable data is shown. | Posted | | Mean | Standard Deviation | g/L | | Baseline, Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Theranova 400 | Three (3) dialysis sessions per week in an in-center setting over 24-week period. Theranova 400 dialyzer: Patients should continue with their pre-study hemodialysis prescriptions (in terms of treatment time, blood flow rate and dialysate flow rate) and prescriptions should be kept stable throughout the study. | | OG001 | Elisio-17H | Three (3) dialysis sessions per week in an in-center setting over 24-week period. Elisio-17H dialyzer: Patients should continue with their pre-study hemodialysis prescriptions (in terms of treatment time, blood flow rate and dialysate flow rate) and prescriptions should be kept stable throughout the study. |
| |
| Secondary | Change From Baseline in Globulin (g/L) at End of Study (up to Week 24) | | FAS. Number of subjects (n) with evaluable data is shown. | Posted | | Mean | Standard Deviation | g/L | | Baseline, Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Theranova 400 | Three (3) dialysis sessions per week in an in-center setting over 24-week period. Theranova 400 dialyzer: Patients should continue with their pre-study hemodialysis prescriptions (in terms of treatment time, blood flow rate and dialysate flow rate) and prescriptions should be kept stable throughout the study. | | OG001 | Elisio-17H | Three (3) dialysis sessions per week in an in-center setting over 24-week period. Elisio-17H dialyzer: Patients should continue with their pre-study hemodialysis prescriptions (in terms of treatment time, blood flow rate and dialysate flow rate) and prescriptions should be kept stable throughout the study. |
| |
| Secondary | Change From Baseline in High-sensitivity C-reactive Protein (mg/L) at End of Study (up to Week 24) | | FAS. Number of subjects (n) with evaluable data is shown. | Posted | | Mean | Standard Deviation | mg/L | | Baseline, Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Theranova 400 | Three (3) dialysis sessions per week in an in-center setting over 24-week period. Theranova 400 dialyzer: Patients should continue with their pre-study hemodialysis prescriptions (in terms of treatment time, blood flow rate and dialysate flow rate) and prescriptions should be kept stable throughout the study. | | OG001 | Elisio-17H | Three (3) dialysis sessions per week in an in-center setting over 24-week period. Elisio-17H dialyzer: Patients should continue with their pre-study hemodialysis prescriptions (in terms of treatment time, blood flow rate and dialysate flow rate) and prescriptions should be kept stable throughout the study. |
| |
| Secondary | Change From Baseline in Prothrombin Activity (%) at End of Study (up to Week 24) | | FAS. Number of subjects (n) with evaluable data is shown. | Posted | | Mean | Standard Deviation | percentage activity | | Baseline, Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Theranova 400 | Three (3) dialysis sessions per week in an in-center setting over 24-week period. Theranova 400 dialyzer: Patients should continue with their pre-study hemodialysis prescriptions (in terms of treatment time, blood flow rate and dialysate flow rate) and prescriptions should be kept stable throughout the study. | | OG001 | Elisio-17H | Three (3) dialysis sessions per week in an in-center setting over 24-week period. Elisio-17H dialyzer: Patients should continue with their pre-study hemodialysis prescriptions (in terms of treatment time, blood flow rate and dialysate flow rate) and prescriptions should be kept stable throughout the study. |
| |
| Secondary | Change From Baseline in Albumin (g/dL) at End of Study (up to Week 24) | | FAS. Number of subjects (n) with evaluable data is shown. | Posted | | Mean | Standard Deviation | g/dL | | Baseline, Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Theranova 400 | Three (3) dialysis sessions per week in an in-center setting over 24-week period. Theranova 400 dialyzer: Patients should continue with their pre-study hemodialysis prescriptions (in terms of treatment time, blood flow rate and dialysate flow rate) and prescriptions should be kept stable throughout the study. | | OG001 | Elisio-17H | Three (3) dialysis sessions per week in an in-center setting over 24-week period. Elisio-17H dialyzer: Patients should continue with their pre-study hemodialysis prescriptions (in terms of treatment time, blood flow rate and dialysate flow rate) and prescriptions should be kept stable throughout the study. |
| |
| Secondary | Change From Baseline in Factor XIV Activity (%) at End of Study (up to Week 24) | | FAS. Number of subjects (n) with evaluable data is shown. | Posted | | Mean | Standard Deviation | percentage activity | | Baseline, Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Theranova 400 | Three (3) dialysis sessions per week in an in-center setting over 24-week period. Theranova 400 dialyzer: Patients should continue with their pre-study hemodialysis prescriptions (in terms of treatment time, blood flow rate and dialysate flow rate) and prescriptions should be kept stable throughout the study. | | OG001 | Elisio-17H | Three (3) dialysis sessions per week in an in-center setting over 24-week period. Elisio-17H dialyzer: Patients should continue with their pre-study hemodialysis prescriptions (in terms of treatment time, blood flow rate and dialysate flow rate) and prescriptions should be kept stable throughout the study. |
| |
| Secondary | Change From Baseline in Tumor Necrosis Factor (pg/mL) at End of Study (up to Week 24) | | FAS. Number of subjects (n) with evaluable data is shown. | Posted | | Mean | Standard Deviation | pg/mL | | Baseline, Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Theranova 400 | Three (3) dialysis sessions per week in an in-center setting over 24-week period. Theranova 400 dialyzer: Patients should continue with their pre-study hemodialysis prescriptions (in terms of treatment time, blood flow rate and dialysate flow rate) and prescriptions should be kept stable throughout the study. | | OG001 | Elisio-17H | Three (3) dialysis sessions per week in an in-center setting over 24-week period. Elisio-17H dialyzer: Patients should continue with their pre-study hemodialysis prescriptions (in terms of treatment time, blood flow rate and dialysate flow rate) and prescriptions should be kept stable throughout the study. |
| |
| Secondary | Change From Baseline in Factor VII Activity (%) at End of Study (up to Week 24) | | FAS. Number of subjects (n) with evaluable data is shown. | Posted | | Mean | Standard Deviation | percentage activity | | Baseline, Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Theranova 400 | Three (3) dialysis sessions per week in an in-center setting over 24-week period. Theranova 400 dialyzer: Patients should continue with their pre-study hemodialysis prescriptions (in terms of treatment time, blood flow rate and dialysate flow rate) and prescriptions should be kept stable throughout the study. | | OG001 | Elisio-17H | Three (3) dialysis sessions per week in an in-center setting over 24-week period. Elisio-17H dialyzer: Patients should continue with their pre-study hemodialysis prescriptions (in terms of treatment time, blood flow rate and dialysate flow rate) and prescriptions should be kept stable throughout the study. |
| |
| Secondary | Change From Baseline in Lambda Light Chain, Free (mg/L) at End of Study (up to Week 24) | | FAS. Number of subjects (n) with evaluable data is shown. | Posted | | Mean | Standard Deviation | mg/L | | Baseline, Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Theranova 400 | Three (3) dialysis sessions per week in an in-center setting over 24-week period. Theranova 400 dialyzer: Patients should continue with their pre-study hemodialysis prescriptions (in terms of treatment time, blood flow rate and dialysate flow rate) and prescriptions should be kept stable throughout the study. | | OG001 | Elisio-17H | Three (3) dialysis sessions per week in an in-center setting over 24-week period. Elisio-17H dialyzer: Patients should continue with their pre-study hemodialysis prescriptions (in terms of treatment time, blood flow rate and dialysate flow rate) and prescriptions should be kept stable throughout the study. |
| |
| Secondary | Change From Baseline in Interleukin 6 (pg/mL) at End of Study (up to Week 24) | | FAS. Number of subjects (n) with evaluable data is shown. | Posted | | Mean | Standard Deviation | pg/mL | | Baseline, Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Theranova 400 | Three (3) dialysis sessions per week in an in-center setting over 24-week period. Theranova 400 dialyzer: Patients should continue with their pre-study hemodialysis prescriptions (in terms of treatment time, blood flow rate and dialysate flow rate) and prescriptions should be kept stable throughout the study. | | OG001 | Elisio-17H | Three (3) dialysis sessions per week in an in-center setting over 24-week period. Elisio-17H dialyzer: Patients should continue with their pre-study hemodialysis prescriptions (in terms of treatment time, blood flow rate and dialysate flow rate) and prescriptions should be kept stable throughout the study. |
| |
| Secondary | Change From Baseline in Complement Factor D (mcg/mL) at End of Study (up to Week 24) | | FAS. Number of subjects (n) with evaluable data is shown. | Posted | | Mean | Standard Deviation | mcg/mL | | Baseline, Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Theranova 400 | Three (3) dialysis sessions per week in an in-center setting over 24-week period. Theranova 400 dialyzer: Patients should continue with their pre-study hemodialysis prescriptions (in terms of treatment time, blood flow rate and dialysate flow rate) and prescriptions should be kept stable throughout the study. | | OG001 | Elisio-17H | Three (3) dialysis sessions per week in an in-center setting over 24-week period. Elisio-17H dialyzer: Patients should continue with their pre-study hemodialysis prescriptions (in terms of treatment time, blood flow rate and dialysate flow rate) and prescriptions should be kept stable throughout the study. |
| |
| Secondary | Change From Baseline in Kappa Light Chain, Free (mg/L) at End of Study (up to Week 24) | | FAS. Number of subjects (n) with evaluable data is shown. | Posted | | Mean | Standard Deviation | mg/L | | Baseline, Week 24 | | | | ID | Title | Description |
|---|
| OG000 | Theranova 400 | Three (3) dialysis sessions per week in an in-center setting over 24-week period. Theranova 400 dialyzer: Patients should continue with their pre-study hemodialysis prescriptions (in terms of treatment time, blood flow rate and dialysate flow rate) and prescriptions should be kept stable throughout the study. | | OG001 | Elisio-17H | Three (3) dialysis sessions per week in an in-center setting over 24-week period. Elisio-17H dialyzer: Patients should continue with their pre-study hemodialysis prescriptions (in terms of treatment time, blood flow rate and dialysate flow rate) and prescriptions should be kept stable throughout the study. |
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| Secondary | Change From Baseline in Beta-2 Microglobulin (mg/L) at End of Study (up to Week 24) | | FAS. Number of subjects (n) with evaluable data is shown. | Posted | | Mean | Standard Deviation | mg/L | | Baseline, Week 24 | | | | ID | Title | Description |
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| OG000 | Theranova 400 | Three (3) dialysis sessions per week in an in-center setting over 24-week period. Theranova 400 dialyzer: Patients should continue with their pre-study hemodialysis prescriptions (in terms of treatment time, blood flow rate and dialysate flow rate) and prescriptions should be kept stable throughout the study. | | OG001 | Elisio-17H | Three (3) dialysis sessions per week in an in-center setting over 24-week period. Elisio-17H dialyzer: Patients should continue with their pre-study hemodialysis prescriptions (in terms of treatment time, blood flow rate and dialysate flow rate) and prescriptions should be kept stable throughout the study. |
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